MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE; FCG,BIOPSY NEEDLE

Model Number	G52012
Medical Device Problem Codes	Structural Problem (2506); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Needle couldn't be extended."as per cc form": the needle-system was pushed through the eus-device until the sheath-tip was out of the device.The needle itself could then only be pushed out with the great resistance, and the sheath was perforated.A second needle was then inserted without difficulty, and the intervention was successfully.Please describe the location in the body for the intended target site (pancreas, stomach, lungs, etc.) (if lungs, which lymph node was being targeted? e.G., 2r, 2l, 4r, ao, ar, 11ri, 11s, etc.) from the stomach to the left intrahepatic bile duct.Please describe the size of the intended target site.From the stomach to the dhc, approx.5 cm.Was gaining access to the target site difficult? n/a, yes, no.Yes.Was puncture of the targeted site difficult? yes.Was the device used in a tortuous position? no.Are images of the device or procedure available? n/a, yes, no.No.Was the device damaged in packaging before removal? n/a, yes, no.Was the device damaged on removal from packaging? n/a, yes, no.No.Was force required to remove the device? n/a, yes, no.No.10.When was the issue noted? e.G., on advancement of the sheath/needle or on needle retraction? advancement of the needle.Were any other defects (other than the complaint issue) observed on the delivery system (e.G., kinks) prior to return? (if yes, please specify what additional defect(s) were observed and where on the device this was observed).No.Was their difficulty locking the sheath (or needle) in place or slipping experienced during use? no.Was the stylet fully in place inside the needle when advancing into the targeted site? yes.
Additional Manufacturer Narrative
Device evaluation: 1 unit of lot number c2291999 of echo-hd-19-a was returned for evaluation, opened not in its original packaging.The device related to this occurrence underwent a laboratory evaluation on the 1st of october 2025.On evaluation of the devices the following observations were made: visual inspection: sheath examined, and perforation observed at 0.3cm from the tip of the sheath at the distal end.(ipe of ruler (ipe0402) calibration due jan 2035) stylet examined and no issue observed.Distal end of needle examined and no issue observed.Functional inspection: sheath extender advance and retract without issue.Needle handle unable to advance.Stylet removed from the device with no issue.Stylet re-inserted into the device without issue.Needle removed from the device and no issue observed.Needle handle then able to advance and retract with no issue.The reported failure was observed.Manufacturing records: prior to distribution, all echo-hd-19-a devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for echo-hd-19-a of lot number c2291999 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and / label: the ¿notes¿ section of the instructions for use, ifu0050 which accompanies this device instructs the user to; "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use¿.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0050) image review: an image was not returned for evaluation.Root cause analysis a definitive cause could not be determined from the investigation.The root cause analysis indicates that sheath damage was likely caused by excessive force applied during the procedure.The resistance experienced when attempting to push the needle out due to difficulties encountered when attempting to penetrate the target site, as described in additional information and description of event, suggests that significant force was needed to advance the needle.This increased force may have led to the sheath being pierced during the attempt to penetrate the target site.Confirmation of complaint is confirmed based on visual and/or functional inspection.Corrective action/correction complaints of this nature will continue to be monitored for similar events.Summary of investigation according to the customer: the needle itself could only be pushed out with the great resistance, and the sheath was perforated.Confirmed quantity, 01 device was confirmed used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude that a definitive root cause could not be determined.The root cause analysis indicates that sheath damage was likely caused by excessive force applied during the procedure.The resistance experienced when attempting to push the needle out due to difficulties encountered when attempting to penetrate the target site, as described in additional information and description of event, suggests that significant force was needed to advance the needle.This increased force may have led to the sheath being pierced during the attempt to penetrate the target site.Complaints of this nature will continue to be monitored for similar events.Complaint is confirmed based on visual and/or functional inspection.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 20-oct-25.

• Brand Name: ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
• Common Device Name: FCG,BIOPSY NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 22919933
• Report Number: 3001845648-2025-00443
• Device Sequence Number: 13047482
• Product Code: FCG
• UDI-Device Identifier: 00827002520127
• UDI-Public: (01)00827002520127(17)280425(10)C2291999
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: K092359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G52012
• Device Catalogue Number: ECHO-HD-19-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/07/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown